QC Lab Technician
Proclinical is currently recruiting for a QC Lab Technician with a pharmaceutical company located in Marietta, PA.
- Perform microbiology testing (Bioburden and plate reading), sample incubation, and Environmental Monitoring data review.
- Cross train on other assays to act as backup for scientists.
- Perform Environmental Monitoring duties related to viable air, viable surfaces, swabs, and non-viable air sample collection as well as performing utility sampling. Perform associated sample reads/testing.
- Generate all paperwork and labels associated with sampling to meet SOP requirements. Collect PEMS data.
- Responsible for assisting senior staff with the harmonization of compendial methods with other vaccine sites. This will include the review of documents, identification of potential gaps and revision of those documents. Handle special projects such as abnormal test results, investigations and validation studies as needed. Identify data trends and escalate as needed.
- Responsible for maintaining and ordering sufficient reagents and supplies, ordering equipment and maintaining the equipment in good working conditions in a calibrated and validated status. Performing routine laboratory tasks such as safety shower/eyewash checks, preparation of autoclaved materials, performing glass-wash and stocking supplies, daily pH meter and balance calibration, etc. Ensure labs are in a 'GMP, safe, analytical-testing readiness' state.
- Assure that all required documentation including records and logs, is complete and accurate according to the current GMPs. File and archive laboratory records and data in accordance with GMPs and SOPs.
- Revise and write change controls, SOP's, and other GMP documents as required.
- When assigned to rotating shift work; work independently and without direct supervision to perform normal operating routines and emergency response procedures.
- Communicate and report status of operations as well as variances to supervisors. Take appropriate actions and escalate issues immediately.
- Perform all tasks with a safety mindset. Following the EHS guidelines established on site.
Skills and Requirements:
- or B.S. in a scientific discipline preferred
- Prefer minimum of two years GMP laboratory testing experience (raw materials, wet chemistry,
compendial testing, packaging components), or Assoc. or B.S. in biology, microbiology, chemistry or related field with minimum of one year GxP experience.
- Knowledge of standard laboratory technique.
- Computer skills required in Excel and Word.
- Ability to follow written procedures and document results in a neat and precise manner.
- Must be well organized, flexible, open-minded and dynamic.
- Must have demonstrated self-direct work habits and strong communication skills.
- Must be a committed team player prepared to work in and embrace a team based culture.
- Ability to work within a multi-skilled team.
- Maintain attention to detail, while completing multiple or repetitive tasks.
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
- Maintain a high level of integrity while balancing multiple priorities and responsibilities.
- Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.